Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology (EDHITO)

  • End date
    Sep 23, 2023
  • participants needed
  • sponsor
    Institut Cancerologie de l'Ouest
Updated on 28 February 2022
kidney cancer


The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI


This study aims to highlight the impact of Patient Therapeutic Education (TPE) in oncology. TPE is an integral part of the care pathway for patients with a chronic pathology such as diabetes, asthma, chronic obstructive pulmonary disease, cardiovascular diseases requiring anticoagulants, haemophilia, renal failure, HIV infection, autoimmune diseases etc.... front of therapeutic progress, many cancers are now taken for a chronic disease.

In oncology, TPE starts to grow. Indeed, TPE makes the patient more autonomous, which could reduce the occurrence and / or aggravation of some toxicities, improve the quality of life, the effectiveness of treatment and optimize health costs. Therefore, it is important to develop programme of therapeutic education in oncology.

The toxicity of ICI is unusual and sometimes lethal. This toxicity must be recognized and managed quickly to maintain a satisfactory dose-intensity. TPE finds its place by raising awareness among patient to the occurrence of these toxicities.

This randomized TPE versus standard care study project will assess the contribution of education in the management of severe toxicities. The investigators believe that changes in patient behaviour will reduce the number of toxicities 3 in the TPE arm.

Condition Therapeutic Patient Education, Immune Checkpoint Inhibitors, Melanoma, Advanced Non-small Cell Lung Cancer, Renal Cell Carcinoma, Head and Neck Cancer, Immune-related Adverse Event
Treatment therapeutic education program, Usual Information
Clinical Study IdentifierNCT03948724
SponsorInstitut Cancerologie de l'Ouest
Last Modified on28 February 2022


Yes No Not Sure

Inclusion Criteria

Patient with Melanoma, Non-Small Cell Bronchial Cancer, renal cell carcinoma, Ca carcinomas of the upper airways to be treated with ICI
Patient who has never received treatment by ICI
Informed patient who signed his consent
Age > or = 18 years
Social insurance

Exclusion Criteria

Patient receiving corticosteroid or immunosuppressant 14 days before inclusion
Immunocompromised patient
Uncontrolled brain metastases
Refusal to participate, patient protected by guardianship
Patient unable to understand the study or unable to follow the education sessions
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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